BOSTON SCIENTIFIC - GALWAY GLADIATOR PTA BALLOON DILATION CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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Model Number UNK722 |
Device Problem
Torn Material (3024)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).It is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
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Event Description
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It was reported that balloon circumferential tear occurred.The target lesion was located in a vessel of the arm.Approximately two months ago, a gladiator balloon catheter was selected for use and advanced for dilation.However, during the procedure, the balloon had circumferential tear and the physician had to do a cut down to the vessel to completely retrieve the balloon from the patient's body.The procedure was not completed.No further patient complications were reported and the patient's status is fine.
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Search Alerts/Recalls
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